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Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors

Last updated on April 12, 2018

FOR MORE INFORMATION
Study Location
Highlands Oncology Group
Fayetteville, Arkansas, 72703 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid
tumors that are not amenable for treatment with curative intent in adult patients
with: NSCLC, TNBC, HR+ breast cancer, recurrent platinum sensitive ovarian cancer, UC,
CRPC, and other advanced solid tumors with a BRCA or ATM gene defect

- Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available
from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor
biopsy during the screening period.

- Minimum age in Japan is 20 years.

- ECOG performance status 0 or 1.

- Resolved acute effects of prior therapy

- Adequate bone marrow, renal, and liver function.

- Negative serum pregnancy test at screening.

- Male and female patients able to have children must agree to use 2 effective methods
of contraception throughout the study and for up to 45 days for female patients and
105 days for male patients after the last dose.

- Signed and dated informed consent.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior treatment with a PARP inhibitor.

- Prior immunotherapy with IL-2, IFN-?, or an anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CD137, OX 40, GITR, LAG 3, IDO, TDO,TIM 3, CTLA-4 antibody, or any other antibody
or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
Prior treatment with Sipuleucel-T for patients with mCRPC is allowed.

- Prior anti-cancer therapy within 4 weeks prior to study enrollment. Prior radiation
therapy within 2 weeks prior to enrollment. Prior palliative radiotherapy to
metastatic lesion(s) is permitted, provided it has been completed 2 days prior to
study enrollment and no clinically significant toxicities are expected (eg, mucositis,
esophagitis).

- Major surgery within 4 weeks prior to study enrollment.

- Current use of immunosuppressive medication at the time of study enrollment.

- Known prior or suspected hypersensitivity to investigational products.

- Known history of immune mediated colitis, inflammatory bowel disease, pneumonitis,
pulmonary fibrosis.

- Active or prior autoimmune disease that might deteriorate when receiving an
immunostimulatory agent.

- Prior organ transplantation including allogenic stem-cell transplantation.

- Vaccination within 4 weeks of study enrollment and while on trial is prohibited except
for administration of inactivated vaccines.

- Diagnosis of Myelodysplastic Syndrome.

- Patients with known brain metastases requiring steroids.

- Participation in other studies involving investigational drug(s) within 4 weeks prior
to study participation and/or during study participation.

- Persisting toxicity related to prior therapy >Grade 1

- Known HIV or AIDs-related illness.

- Positive HBV or HCV test indicating acute or chronic infection.

- Active infection requiring systemic therapy.

- Clinically significant cardiovascular disease: cerebral vascular accident/stroke or
myocardial infarction within 6 months prior to study entry; unstable angina,
congestive heart failure or a serious cardiac arrhythmia requiring medication.

- Current or anticipated use of a P glycoprotein (P gp) inhibitor (eg, dronedarone,
quinidine, ranolazine, itraconazole, ketoconazole), strong P gp inducer (eg, rifampin,
ritonavir, tipranavir), or strong inhibitor of breast cancer resistance protein (BCRP)
(eg, elacridar [GF120918]).

- Other acute or chronic medical or psychiatric conditions.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Intravenous injections
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
A placebo is not used in this trial
Duration
The time commitment for participation in the study.
Follow up: Estimated 12 weeks
Screening: Estimated 4 weeks
Treatment: Estimated 36 weeks
Site Visits
Follow up: Range 0 visits
Screening: Range 1 visits
Treatment: Range 1 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Keeping a diary
Mri
Cat scan
Physical examination
Electrocardiogram (ECG)
Biopsy
Urine test
Other
Blood test
Vital signs and measurements
NCT03330405
Pfizer
Recruiting
Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors

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Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors
A Phase 1b/2 Study To Evaluate Safety And Anti Tumor Activity Of Avelumab In Combination With The Poly(Adenosine Diphosphate [Adp]-Ribose) Polymerase (Parp) Inhibitor Talazoparib In Patients With Locally Advanced Or Metastatic Solid Tumors
Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).

Avelumab is a human immunoglobulin (Ig)G1 monoclonal antibody (mAb) directed against programmed death ligand 1 (PD L1). Avelumab selectively binds to PD L1 and competitively blocks its interaction with programmed death receptor 1 (PD 1), thereby interfering with this key immune checkpoint inhibition pathway. Avelumab is currently being investigated as single agent and in combination with other anti cancer therapies in patients with locally advanced or metastatic solid tumors and various hematological malignancies.

Talazoparib is a potent, orally bioavailable poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor, which is cytotoxic to human cancer cell lines harboring gene mutations that compromise deoxyribonucleic acid (DNA) repair, an effect referred to as synthetic lethality, and by trapping PARP protein on DNA thereby preventing DNA repair, replication, and transcription.

Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors
  • Drug: Avelumab Phase 1b
    Avelumab
    Other Name: MSB0010718C
  • Drug: Talazoparib Phase 1b
    Talazoparib
    Other Name: MDV3800, BMN 673
  • Drug: Avelumab Phase 2
    The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
    Other Name: MSB0010718C
  • Drug: Talazoparib Phase 2
    The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
    Other Name: MDV3800, BMN 673
  • Experimental: Dose Level 0 Phase 1b

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 1b
    • Drug: Talazoparib Phase 1b
  • Experimental: Dose Level -1 Phase 1b

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 1b
    • Drug: Talazoparib Phase 1b
  • Experimental: Dose Level -2 Phase 1b

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 1b
    • Drug: Talazoparib Phase 1b
  • Experimental: A1. NSCLC Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: A2. NSCLC PD-L1+ Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: B1. TNBC Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: B2. HR+BC DDR Defect +Assay Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: C1. Ovarian CA Recurrent Plat-Sensitive Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: C2.Ovarian CA Recurrent Plat-Sensitive BRCA defect Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: D.Urothelial CA Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: E1. CRPC Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: E2. CRPC DDR Defect +Assay Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
296
March 28, 2020
March 28, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent in adult patients with: NSCLC, TNBC, HR+ breast cancer, recurrent platinum sensitive ovarian cancer, UC, and CRPC
  • Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor biopsy during the screening period.
  • Minimum age in Japan is 20 years.
  • ECOG performance status 0 or 1.
  • Resolved acute effects of prior therapy
  • Adequate bone marrow, renal, and liver function.
  • Negative serum pregnancy test at screening.
  • Male and female patients able to have children must agree to use 2 highly effective methods of contraception throughout the study and for up to 45 days for female patients and 105 days for male patients after the last dose.
  • Signed and dated informed consent.

Exclusion Criteria:

  • Prior treatment with a PARP inhibitor.
  • Prior immunotherapy with IL-2, IFN-?, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, OX 40, GITR, LAG 3, IDO, TDO,TIM 3, CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. Prior treatment with Sipuleucel-T for patients with mCRPC is allowed.
  • Prior anti-cancer therapy within 4 weeks prior to study enrollment. Prior radiation therapy within 2 weeks prior to enrollment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed 2 days prior to study enrollment and no clinically significant toxicities are expected (eg, mucositis, esophagitis).
  • Major surgery within 4 weeks prior to study enrollment.
  • Current use of immunosuppressive medication at the time of study enrollment.
  • Known prior or suspected hypersensitivity to investigational products.
  • Known history of immune mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
  • Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
  • Prior organ transplantation including allogenic stem-cell transplantation.
  • Vaccination within 4 weeks of study enrollment and while on trial is prohibited except for administration of inactivated vaccines.
  • Diagnosis of Myelodysplastic Syndrome.
  • Patients with known brain metastases requiring steroids.
  • Participation in other studies involving investigational drug(s) within 4 weeks prior to study participation and/or during study participation.
  • Persisting toxicity related to prior therapy >Grade 1
  • Known HIV or AIDs-related illness.
  • Positive HBV or HCV test indicating acute or chronic infection.
  • Active infection requiring systemic therapy.
  • Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study entry; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
  • Current or anticipated use of a strong P glycoprotein (P gp) inhibitor (eg, dronedarone, quinidine, ranolazine, itraconazole, ketoconazole), strong P gp inducer (eg, rifampin, ritonavir, tipranavir), or strong inhibitor of breast cancer resistance protein (BCRP) (eg, elacridar [GF120918]).
  • Other acute or chronic medical or psychiatric conditions.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03330405
B9991025
2017-001509-33 ( EudraCT Number )
JAVELIN PARP MEDLEY ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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